| Product ID | 0121-0925_bdd6aba3-0504-a99b-e053-2995a90a6467 |
| NDC | 0121-0925 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Promethazine VC with Codeine Oral Solution |
| Generic Name | Promethazine And Phenylephrine Hydrochloride And Codeine Phosphate |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-03-18 |
| Marketing Category | ANDA / |
| Application Number | ANDA040660 |
| Labeler Name | Pharmaceutical Associates, Inc. |
| Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/5mL; mg/5mL; mg/5mL |
| Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] |
| DEA Schedule | CV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |